Center for Drug Regulation and Research Food and Drug Administration - - PowerPoint PPT Presentation

▶
center for drug regulation and research food and drug
SMART_READER_LITE
LIVE PREVIEW

Center for Drug Regulation and Research Food and Drug Administration - - PowerPoint PPT Presentation

Nov 24, 2023 276 likes •686 views

Republic of the Philippines Department of Health Food and Drug Administration Importation of Unregistered Drug Products Center for Drug Regulation and Research Food and Drug Administration Presentation Outline I. Food and Drug

slide-1
SLIDE 1

Republic of the Philippines Department of Health Food and Drug Administration

Importation of Unregistered Drug Products

Center for Drug Regulation and Research Food and Drug Administration

slide-2
SLIDE 2

I. Food and Drug Administration

  • II. Use of Unregistered Products

III.Issues for Discussion

Presentation Outline

5 May 2015 2

slide-3
SLIDE 3

Discuss and solicit comments from stakeholders on issues arising from the importation

  • f

unregistered drug products

Objective

slide-4
SLIDE 4

Republic of the Philippines Department of Health Food and Drug Administration

Food and Drug Administration

slide-5
SLIDE 5

To ensure the safety, efficacy, purity, and quality of products we regulate through effective implementation of the national regulatory framework consistent with international best practice

MISSION

5

slide-6
SLIDE 6

To be an internationally recognized center

  • f

regulatory excellence safeguarding the health of the Filipinos

VISION

6

slide-7
SLIDE 7

QUALITY POLICY

Our highest commitment is to ensure the safety, efficacy and quality of health products. Toward this end, we commit to establish science- based standards as basis for regulatory policies, to continually improve and maintain our competencies in relation to our regulatory function, and to deliver quality public service with integrity.

7

slide-8
SLIDE 8

Regulatory Framework Elements

  • 1. Licensing/Accreditation of establishments
  • GMP, GDP, GSP, GCP, and GLP
  • 2. Pre-marketing assessment
  • Quality, safety, and efficacy (for innovative medicines)
  • Quality+interchangeability (for generics)
  • 3. Post-marketing surveillance
  • Safety (benefit/risk balance)
  • Quality (quality testing and compliance monitoring)
  • 4. Communication

8

slide-9
SLIDE 9
  • 1. Pharmacovigilance
  • Safety monitoring of drugs on the market for

unexpected health risks and informing the public of risks posed by specific drugs and other health products;

  • 2. Monitoring, collecting, sampling and testing of drugs
  • 3. Audits

and inspection

  • f

manufacturers/ distributors/ retail outlets

  • 4. Advertisements and claims monitoring
  • 5. Consumer reporting of ADR
  • 6. Product recall / Administrative sanctions

Post-Marketing Surveillance

9

slide-10
SLIDE 10
  • Regulatory safeguards are in place to

protect the public

  • Licensing of establishments, registration of

products, and post licensing and post marketing surveillance

Summary..

slide-11
SLIDE 11

Republic of the Philippines Department of Health Food and Drug Administration

Use of Unregistered Products

slide-12
SLIDE 12

k)a, Sec. 1 General Provision, Article I, Book II

IRR of RA 9711

slide-13
SLIDE 13
  • FDA recognizes the need for drugs and

devices product/preparation which are not registered or are in the process of registration in the Philippines by patients who are terminally or seriously ill.

  • Access to these products for these patients

is morally, socially and ethically justified when there is no existing superior alternative therapy that can likely cure or adequately control their conditions.

5 May 2015 13

slide-14
SLIDE 14

Administrative Order No. 4 s. 1992

5 May 2015 14

slide-15
SLIDE 15

AO No. 4 s. 1992

Compassionate Special Permit for Restricted Use

  • f Unregistered Drug and Devices Product (CSP)
  • a special permit signed by the FDA Director

granting a Specialized Institution (SI) and Specialty Society (SS) the privilege to avail of an unregistered drug and device product through a certain licensed establishment for certain kind/type of patients, specific volume and period.

15 5 May 2015

slide-16
SLIDE 16

AO No. 4 s. 1992

  • For patients suffering from the following

conditions:

  • 1. Acquired Immune Deficiency Syndrome (AIDS)
  • 2. Cancer
  • 3. Life-threatening conditions

5 May 2015 16

slide-17
SLIDE 17

Application shall include:

  • estimated volume needed
  • the licensed drug/ device establishment through

which the unregistered drug may be procured

  • identify the names and address of the specialists

qualified and authorized to use the product

AO No. 4 s. 1992

5 May 2015 17

slide-18
SLIDE 18

Drug

Quantity requested per year Frequency of request

2013 2014 Total 2013 2014 Total Colistimethate Na 1 M Unit vial 7600 37170 44770 13 23 36 Dipyridamole 10mg/2ml ampoule 10333 16382 26715 12 18 30 Glyceryl trinitrate 10mg/10ml amp 14990 9319 24309 8 20 28 Protamine sulfate 50mg/5ml vial 11475 6691 18166 13 22 35 Vasopressin 20 units/ml vial 4425 6895 11320 10 14 24 Adenosine 6mg/2ml vial 3963 5605 9568 15 30 45 Phenylephrine 1% 10mg/1ml vial 2700 4985 7685 9 17 26 Papaverine HCl 30mg/ml, in 2ml vial 1495 2908 4403 8 19 27 Esmolol HCl 10mg/ml, in 10 ml vial 1405 2958 4363 10 21 31 Milrinone lactate 10mg vial 2302 2057 4359 10 14 24 Dantrolene sodium 20mg/65mL vial 408 850 1258 11 20 31

Top Requested Drugs

slide-19
SLIDE 19

Drug

Quantity requested per year Frequency of request

2013 2014 Total 2013 2014 Total

Sotalol 80mg tablet 10400 13030 23430 2 2 4 Propafenone 150mg tablet 4400 14500 18900 1 2 3 Liothyronine (Cynomel) 25mcg tablet 7220 7800 15020 4 4 8 Co-trimoxazole (Trimethoprim 16 mg/ml + Sulfamethoxazole 80 mg/ml) [Bactrim] Solution for injection, in 5ml vial 1450 9112 10562 3 8 11 Fludrocortisone 0.1mg tablet 3100 5800 8900 2 4 6 Provocholine nebulization kit 1700 3400 5100 2 2 4 Provocholine 100mg/vial 288 475 763 2 2 4

Top Requested Drugs

slide-20
SLIDE 20

Hospitals

  • No. of applications per year

2013 2014 Total

  • St. Luke's Medical Center – Global City

6 12 18

  • St. Luke's Medical Center – Quezon City

8 8 16 Cardinal Santos Medical Center 8 7 15 The Medical City 5 7 12 Philippine General Hospital 7 3 10 Makati Medical Center 3 6 9 University of Santo Tomas Hospital 2 6 8 Asian Hospital and Medical Center 2 5 7 Manila Doctors Hospital 2 5 7 Philippine Heart Center 2 2 4

Top Requesting Hospitals

slide-21
SLIDE 21

Republic of the Philippines Department of Health Food and Drug Administration

Issues for Discussion

slide-22
SLIDE 22
  • Misalignment with AO 4
  • Concerns from Hospital Group
  • List of Products

Issues for Discussion

slide-23
SLIDE 23
  • Regular request (from 2 to 12 times a year)

for permit to import of unregistered to be used for critical care, strictly for their own use

  • Quantity is considered to be substantial
  • No specific patients identified

Misalignment with AO 4

slide-24
SLIDE 24
  • 13 April 2015 – representatives from PHA

and PSHP

  • Some of the concerns:

– Hospitals acknowledge the risks – waiver – No choice – no MAH/importer is willing to register due to “low volume” = not profitable – Some drugs are included in the PNDF but not available in the market

Concerns from Hospital Group

slide-25
SLIDE 25

List of Products

Drug Company* Phenylephrine 1% 10mg/1ml vial WEST WARD PHARM CORP; ECLAT PHARMS LLC; Nitroprusside (Nitropress) 50mg/2ml vial HOSPIRA Dantrolene sodium (Revonto) 20mg/65mL vial US WORLDMEDS PAR STERILE PRODUCTS Dipyridamole (Persantin) 10mg/2ml ampoule BEDFORD FRESENIUS KABI USA HIKMA MAPLE Protamine sulfate 10mg/ml, in 5ml vial FRESENIUS KABI USA Thrombin 5000 units/5ml vial PapaverineHCl30mg/ml, in 2ml vial AMERICAN REGENT, INC. Vasopressin (Pitressin) 20 units/ml vial PAR STERILE PRODUCTS Colistimethate sodium (Colomycin) 1 Million Unit vial EMCURE PHARMS LTD; FRESENIUS KABI USA; PADDOCK LLC; AGENT PHARMS; X GEN PHARMS; PAR STERILE PRODUCTS

slide-26
SLIDE 26

List of Products

Drug Company* Milrinone lactate 10mg/10ml vial BEDFORD; FRESENIUS KABI USA; GLAND PHARMA LTD HOSPIRA INC Ferric subsulfate (Astringyn) topical solution Cooper Surgical Adenosine (Adenocor) 6mg/2ml vial AMDIPHARM MERCURY COMPANY LIMITED; FOCUS PHARMACEUTICALS LTD; WOCKHARDT UK LTD EsmololHCl (Brevibloc) 10mg/ml, in 10 ml vial BAXTER HEALTHCARE; EUROHLTH INTL SAR; FRESENIUS KABI USA; LUITPOLD; MYLAN INSTITUTIONAL Thiopental sodium 500mg Powder for Injection Solution, in Vial ARCHIMEDES PHARMA UK LTD Ferric subsulfate (Monsel’s) 8 ml Solution Clique Hemostasis Products

slide-27
SLIDE 27

List of Products

Drug Company* Lidocaine HCl 2% Jelly USP, 30ml tube SAGENT PHARMS; AKORN; INTL MEDICATION; WATSON LABS INC; OAK PHARMS Streptokinase (Streptase) 1.5 Million units, vial BEACON PHARMACEUTICALS; CSL BERHING UK LIMITED Aminocaproic acid 250mg/ml, 20ml vial LUITPOLD; HOSPIRA Calcium chloride 100mg/ml, 10ml vial International Medication Systems (UK) Cyclosporine (Sandimmune) 250mg/5ml ampoule Novartis Pharmaceuticals

slide-28
SLIDE 28

List of Products

Drug Company* Etomidate (Amidate) 2mg/ml, 10ml vial HOSPIRA; AGILA SPECLTS; BEDFORD; EMCURE PHARMS LTD; LUITPOLD; PAR STERILE PRODUCTS; ZYDUS PHARMS USA INC Labetalol HCl injection 100mg/20ml vial AKORN INC; EUROHLTH INTL SARL; GLAND PHARMA LTD; HOSPIRA Metolazone 5mg tablet UCB INC; SANDOZ; MYLAN Pentafluoropropanetetrafluoroethane (Gebauer'spain Ease) 3.5 Oz Medium Stream Spray GABAUER COMPANY

slide-29
SLIDE 29

List of Products

Drug Company* Estriol (Ovestin) Vaginal Cream 1mg/g, 15g tube ASPEN Verapamil HCl 2.5mg/ml ampoule ABBOTT HOSPIRA Trientinedihydrochloride (Syprine) 300mg capsule ATON PHARMA, INC. Isosorbidedinitrate (Isoket) 0.1% 1mg/ml ampoule UCB PHARMA LIMITED Fludrocortisone 0.1mg tablet E.R. SQUIBB & SONS LIMITED Sotalol 120mg tablet COVIS PHARMA SARL; UPSHER SMITH; APOTEX; EPIC PHARMA INC; IMPAX PHARMS; MYLAN; SANDOZ; TEVA; VINTAGE

slide-30
SLIDE 30

List of Products

Drug Company* Sotalol 80mg tablet COVIS PHARMA SARL; UPSHER SMITH; APOTEX INC; EPIC PHARMA INC; IMPAX PHARMS; MYLAN; SANDOZ; TEVA; VINTAGE Diltiazem 5mg/ml, 10ml vial AKORN INC; BEDFORD; HIKMA FARMACEUTICA; HIKMA MAPLE;

slide-31
SLIDE 31

List of Products

Drug Company* Irinotecan 100mg/5ml vial PFIZER INC; ACCORD HLTHCARE; ACTAVIS TOTOWA; AKORN; BEDFORD LABS; CIPLA LTD; DR REDDYS LABS LTD; EBEWE PHARMA; EMCURE PHARMS LTD; FRESENIUS KABI ONCOL; FRESENIUS KABI USA; HIKMA FARMACEUTICA; HISUN PHARM HANGZHOU; HOSPIRA; JIANGSU HENGRUI MED; MUSTAFA NEVZAT ILAC; PLIVA LACHEMA; SUN PHARMA GLOBAL; TEVA PHARMS USA

slide-32
SLIDE 32

List of Products

Drug Company* Pentamidine isethionate 300mg vial FRESENIUS KABI USA Argatroban (Acova) 250mg/2.5ml Single-use vial PFIZER; HIKMA PHARM CO LTD; MYLAN INSTITUTIONAL; PAR STERILE PRODUCTS; FRESENIUS KABI USA Melphalan 50mg vial ASPEN Fludarabine (Fludara) 50mg vial SANOFI Alprostadil (Caverject) 40mcg/ml vial PFIZER, INC. PHARMACIA AND UPJOHN; AUXILIUM PHARMS LLC Busulfan (Myleran) 2mg tablet ASPEN GLOBAL Azacitidine 100mg vial DR REDDYS LABS LTD; CELGENE

slide-33
SLIDE 33

List of Products

Drug Company* Naltrexone HCl 50mg tablet ACCORD HLTHCARE; BARR; ELITE LABS; TEVA WOMENS; SUN PHARMA GLOBAL; MALLINCKRODT Chemet 100mg capsule RECORDATI RARE Liothyronine (Cynomel) 25mcg tablet KING PHARMS R AND D; COASTAL PHARMS; MYLAN; SIGMAPHARM LABS LLC Liothyronine 50mcg tablet KING PHARMS R AND D; COASTAL PHARMS; MYLAN; SIGMAPHARM LABS LLC

slide-34
SLIDE 34

List of Products

Drug Company* Carmustine (BCNU) 100mg vial EMCURE PHARMS LTD Edrophonium 10mg/ml ampoule MYLAN INSTITUTIONAL Hydroxyprogesteronecaproate (Proluton depot) 250mg/ml ampoule LUMARA HEALTH INC Bendamustine 100mg vial CEPHALON Propafenone 150mg tablet ANI PHARMS INC; MUTUAL PHARM;; VINTAGE PHARMS GLAXOSMITHKLINE LLC Propafenone 300mg tablet ANI PHARMS INC; MUTUAL PHARM VINTAGE PHARMS; GLAXOSMITHKLINE LLC Quinidine sulfate 200mg tablet MUTUAL PHARM; ATSON LABS; SANDOZ

slide-35
SLIDE 35

List of Products

Drug Company* Potassium acid phosphate 10mmol/10ml ampoule MARTINDALE PHARMACEUTICALS LTD Sodium tetra decylsulfate (Fibrovein) 3% 2ml ampoule STD PHARMACEUTICAL PRODUCTS LT Procainamide 100mg/ml, 10ml vial HOSPIRA Alprostadil 500mcg/ml ampoule PHARMACIA AND UPJOHN TEVA PHARMS USA EUROHLTH INTL SARL Phentolaminemesylate 10mg/ml ampoule BEDFORD LABORATORIES SAMARTH PHARMA PVT. LTD. MidodrineHCl 10mg tablet APOTEX INC IMPAX PHARMS MYLAN PHARMS IN SANDOZ UPSHER SMITH Cinacalcet HCl (Mimpara) 30mg tablet AMGEN

slide-36
SLIDE 36

List of Products

Drug Company* Cinacalcet HCl (Mimpara) 60mg tablet AMGEN Ora-Plus Oral Suspending Vehicle 473ml PADDOCK LABORATORIES Potassium Iodide (Jodid) 100mcg tablet MERCK Glycopyrrolate 0.2mg/ml, in 5 ml vial AMDIPHARM MERCURY COMPANY LIMITED Fluorescein Injection ALCON LABORATORIES UK LIMITED Glyceryl trinitrate 10mg/10ml ampoule LUITPOLD; HAMELN PHARMA PLUS GMBH; MERCURY PHARMA INTERNATIONAL LTD Rho(D) Immune Globulin Intravenous Human 1500 IU (300mcg) per 3ml, lyophilized powder for injection, in vial JOHNSON & JOHNSON Isoproterenol (Isoprenaline) 0.2mg/ml, 1ml ampoule HOSPIRA

slide-37
SLIDE 37

List of Products

Drug Company* Co-trimoxazole (Trimethoprim 16 mg/ml + Sulfamethoxazole 80 mg/ml) [Bactrim] Solution for injection, in 5ml vial INTERNATIONAL APEX PHARMACEUTICALS, INC. MUTUAL PHARM Metolazone 2mg tablet SANDOZ Dantrolene sodium 20mg tablet PAR STERILE PRODUCTS NORGINE LIMITED IMPAX LABS MIKAH PHARMA Provocholine 100mg/vial METHAPHARM INC. Provocholine nebulization kit METHAPHARM INC.

slide-38
SLIDE 38
  • Foreign supplier has local counterpart, yet

products are not registered due to “low demand”

List of Products

slide-39
SLIDE 39
  • Mandatory registration will be required for

the products

– MAH will have prioritized review – Pending applications of CSP may be granted one last time

Recommendations

slide-40
SLIDE 40